Trial reportTrials2026
Randomized, double-blind, placebo-controlled study of oral duloxetine in prevention of acute pain syndrome in breast cancer patients receiving paclitaxel (DOPA study).
Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
backgroundAcute pain syndrome (APS) is a common side effect of paclitaxel therapy. To date, there is no standard of care to prevent APS in patients receiving paclitaxel. Through this study, we aim to assess whether oral duloxetine reduces the incidence of paclitaxel-induced APS (P-APS) as compared to placebo.
methodsThis is a multi-centric, randomized (1:1), double-blind, placebo-controlled, parallel-group superiority trial. A total of 204 patients with breast cancer planned to receive paclitaxel will be randomly assigned to receive either oral duloxetine or a matched placebo for 7 days after paclitaxel infusions for 4 cycles. The primary objective of the study is to compare the proportion of patients who develop P-APS in two groups. Key secondary objectives are to compare the quality of life (using the FACT-B scale), the incidence of peripheral neuropathy, the safety profile, and adherence with duloxetine. Patient-reported outcomes for P-APS and neuropathy will be assessed at the end of each cycle using BPI-SF and EORTC-CIPN20 questionnaires, respectively. DISCUSSION: The DOPA study is designed to evaluate whether oral duloxetine can reduce the occurrence of APS in patients receiving paclitaxel chemotherapy for breast cancer. Limited trials have assessed P-APS prevention using etoricoxib, dexamethasone, and pregabalin, but no pharmacological measure is effective. If the trial successfully meets its primary endpoint, oral duloxetine could become the new standard of care for preventing paclitaxel-induced APS.
trial registrationClinical Trials Registry of India - CTRI/2024/10/075636. Registered on 22 October 2024.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.